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Completed

NCT Number: NCT02679781

Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care

The general objective of the study is to compare the efficacy of administering midazolam orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure: 1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum working time.

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Key information

Conditions

Conscious Sedation

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, 91120, Israel

About this study

  • Prospective, parallel design
  • Study and control group: 100 healthy children (ASA 1), ages: 2-6 years, uncooperative (Frankl 1-2), that needs at least two similar dental treatments. Exclusion criteria: enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = >75% airway obstruction), upper respiratory tract infection or nasal discharge.
  • Randomization: At the first appointment the subjects will assigned randomly to receive oral midazolam or nasal midazolam;
  • Sedation: oral midazolam dose is 0.5mg/kg. Nasal midazolam dose is 0.2mg/kg. During treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
  • Acceptability of the medication: compliance in taking the medication will be assessed and recorded as: willingly, coaxed, forced, or failed (not administered).
  • Behavior during dental treatment: Houpt scale measures behavior by rating sleep, movement, crying and overall behavior. The degree of alertness, movement and crying will be assessed before, during (every 5 min) and after the operative procedure. The rating will be done by one observer blind to the route of administration. This blind observer will also monitor the pulse and oxygen saturation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy children (ASA 1), uncooperative (Frankl 1-210), that needs at least two similar dental treatments.

Exclusion criteria

  • enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = >75% airway obstruction), upper respiratory tract infection or nasal discharge.

Treatment and study plan

oral midazolam

Drug

administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.

Other names: oral dormicum

nasal midazolam

Drug

administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.

Other names: nasal dormicum

Primary outcomes

  1. Number of Participants Compliant With Oral or Nasal Midazolam Administration

    Time frame: the compliance in taking the medication will be assessed at the time of administration and recorded immediately.

    the compliance in taking the medication will be assessed at the time of administration by one of the investigators and recorded immediately as: willingly, coaxed, forced, or failed (not administered).

Secondary outcomes

  1. Behavior During Dental Treatment

    Time frame: the effect of oral or nasal midazolam on behaviour will be assessed during dental treatment.The length of each treatment is estimated as 30-45 minutes.

    the effect of oral or nasal midazolam on behaviour will be assessed by blind observer using Houpt scale. Houpt scale measures behavior by rating overall behavior. the scale is 1 to 6, higher score mean a better behavior.

    • = Aborted, no treatment rendered.
    • = Poor, treatment interrupted, only partial treatment was completed 3= Fair, treatment interrupted but eventually completed 4= Good, difficult but all treatment was performed 5= Very good, some limited crying or movement 6= Excellent, no crying or movement

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2016
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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